Akeso Biopharma Co., Ltd.
FDA inspection history in Zhongshan, China, 2023
- 1
- Form 483
Every document, by year
- Form 483
2023: one Form 483.
The story so far
Built from the dates and citations on the documents themselves.
- 2023One Form 483, at Zhongshan, China.
Cited most
Across all Akeso Biopharma Co. observations on file
- 21 CFR 211.100Written procedures; deviations2
- 21 CFR 211.113Control of microbiological contamination2
- 21 CFR 211.110Sampling and testing of in-process materials and drug products1
- 21 CFR 211.192Production record review1
- 21 CFR 211.67Equipment cleaning and maintenance1
The complete Akeso Biopharma Co. file.
All 1 documents as original PDFs. For supplier audits, diligence and inspection prep.
Sites
Zhongshan, China
One Form 483 · 2023 · 8 observations
Latest: Form 483, Aug 7, 2023 →
Documents
1 on file, newest first| Date | Document | Location | Observations | Price |
|---|---|---|---|---|
| 2023-08-07 | 483 Form 483 | Zhongshan, China | 8 | $99 |
FEI number 3017057933 · most recent document Aug 7, 2023
About Akeso Biopharma Co., Ltd.
How many FDA Form 483s has Akeso Biopharma Co., Ltd. received?
FDA Intel has 1 Form 483 on file for Akeso Biopharma Co., Ltd.; the most recent is dated Aug 7, 2023.
When was Akeso Biopharma Co., Ltd. last inspected by FDA?
The most recent FDA inspection document on file for Akeso Biopharma Co., Ltd. is a Form 483 dated Aug 7, 2023, for the site in Zhongshan, China.
What did FDA cite at Akeso Biopharma Co., Ltd.?
The regulations cited most in the observations on file for Akeso Biopharma Co., Ltd. are 21 CFR 211.100 (Written procedures; deviations), 2 times; 21 CFR 211.113 (Control of microbiological contamination), 2 times; 21 CFR 211.110 (Sampling and testing of in-process materials and drug products), 1 time.